Effects of Diaphragmatic and Abdominal Neuromuscular Electrical Stimulation in Post-PCI Patients
Effects of Diaphragmatic and Abdominal Neuromuscular Electrical Stimulation on Arterial Blood Gases, Pulmonary Function, Ejection Fraction and Functional Capacity in Post-PCI Patients
연구 개요
상태
정황
상세 설명
Percutaneous coronary intervention (PCI) improves coronary blood flow in patients with coronary artery disease; however, many patients continue to experience reduced pulmonary function, impaired gas exchange, decreased cardiac performance, and limited functional capacity after the procedure. These issues are often related to respiratory muscle weakness, immobilization, and altered ventilatory mechanics. Conventional cardiac rehabilitation focuses mainly on aerobic and resistance training, with limited emphasis on respiratory muscle strengthening.
Neuromuscular electrical stimulation (NMES) is a non-invasive technique that induces muscle contractions and may enhance both inspiratory and expiratory muscle function when applied to the diaphragm and abdominal muscles. This study aims to evaluate the effectiveness of combined diaphragmatic and abdominal NMES as an adjunct to standard cardiac rehabilitation in post-PCI patients.
In this randomized controlled trial, 42 hemodynamically stable patients aged 40-75 years will be randomly assigned to either an intervention group (NMES plus standard rehabilitation) or a control group (standard rehabilitation alone). The NMES intervention will be applied for 30 minutes per session, five days per week, for two weeks.
Outcome measures will include arterial blood gases (PaO₂, PaCO₂, SaO₂), pulmonary function (FVC, FEV₁, PEFR), left ventricular ejection fraction, and functional capacity assessed by the 6-minute walk test. Assessments will be conducted at baseline and after the intervention.
This study aims to determine whether NMES can improve respiratory and functional outcomes and serve as an effective adjunct to conventional cardiac rehabilitation in post-PCI patients.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Arjumand Bano, MS
- 전화번호: +92 305 9551883
- 이메일: arjumand.bano@riphah.edu.pk
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged 40-75 years
- Patients who have undergone successful percutaneous coronary intervention (PCI) for stable or acute coronary syndrome
- Hemodynamically stable (no inotropic support, no active arrhythmias)
- Left ventricular ejection fraction (LVEF) ≥ 35%
- Able to perform spirometry and 6-minute walk test (6MWT)
- Willing to participate and provide informed consent
Exclusion Criteria:
- Significant arrhythmias or pacemaker/implantable defibrillator not cleared for NMES
- Severe pulmonary disease (e.g., advanced COPD, pulmonary fibrosis) affecting lung function independently
- Neuromuscular disorders interfering with NMES application
- Recent stroke or severe cognitive impairment limiting participation
- Active infection, sepsis, or systemic inflammatory disease
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: NMES + Standard Cardiac Rehabilitation
Participants in this group will receive combined diaphragmatic and abdominal neuromuscular electrical stimulation (NMES) in addition to standard cardiac rehabilitation.
NMES will be applied using surface electrodes placed over the lower thoracic region (for diaphragmatic stimulation) and abdominal muscles (rectus abdominis and external obliques).
The intervention will be delivered for 30 minutes per session, five days per week, for two weeks, along with routine cardiac rehabilitation including aerobic exercise, breathing exercises, and education.
|
A dual-channel electrical stimulation device will be used to deliver stimulation to respiratory muscles.
Surface electrodes will be placed over the lower thoracic region for diaphragmatic stimulation and over the abdominal muscles for expiratory muscle stimulation.
Stimulation parameters will include a frequency of 30-50 Hz, pulse width of 300 µs, and a duty cycle of 5 seconds on and 5 seconds off.
Intensity will be adjusted to achieve visible muscle contraction without discomfort.
Sessions will last 30 minutes, five days per week, for two weeks.
다른 이름들:
|
|
활성 비교기: Standard Cardiac Rehabilitation
Participants in this group will receive standard cardiac rehabilitation only, including aerobic exercise, breathing exercises, and patient education as per institutional protocol, without the use of neuromuscular electrical stimulation (NMES).
|
A structured cardiac rehabilitation program including aerobic exercise, breathing exercises, and patient education delivered according to institutional protocols, without the use of neuromuscular electrical stimulation.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Partial Pressure of Oxygen (PaO₂)
기간: Baseline and after 2 weeks of intervention
|
Measurement of arterial partial pressure of oxygen using arterial blood gas analysis.
|
Baseline and after 2 weeks of intervention
|
|
Partial Pressure of Carbon Dioxide (PaCO₂)
기간: Baseline and after 2 weeks of intervention
|
Measurement of arterial partial pressure of carbon dioxide using arterial blood gas analysis.
|
Baseline and after 2 weeks of intervention
|
|
Arterial Oxygen Saturation (SaO₂)
기간: Baseline and after 2 weeks of intervention
|
Measurement of arterial oxygen saturation using arterial blood gas analysis.
|
Baseline and after 2 weeks of intervention
|
|
Forced Vital Capacity (FVC)
기간: Baseline and after 2 weeks of intervention
|
Assessment of forced vital capacity using spirometry.
|
Baseline and after 2 weeks of intervention
|
|
Forced Expiratory Volume in 1 Second (FEV₁)
기간: Baseline and after 2 weeks of intervention
|
Assessment of forced expiratory volume in 1 second using spirometry.
|
Baseline and after 2 weeks of intervention
|
|
Peak Expiratory Flow Rate (PEFR)
기간: Baseline and after 2 weeks of intervention
|
Assessment of peak expiratory flow rate using spirometry.
|
Baseline and after 2 weeks of intervention
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Left Ventricular Ejection Fraction (LVEF)
기간: Baseline and after 2 weeks
|
Measurement of cardiac function using echocardiography (Simpson's biplane method).
|
Baseline and after 2 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Arjumand Bano, MS, Riphah International University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- REC/RCR & AHS/25/0322
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .